Study to Evaluate the Safety and Efficacy of Denosumab and Actonel® in Post Menopausal Women Transitioned From Alendronate Therapy

Summary

A randomized, open label study to assess the safety and effectiveness of Denosumab, administered every 6 months and Actonel ® (Risedronate), administered monthly in post menopausal women transitioned from weekly or daily Alendronate therapy.

Timeline

Start

2009-09-01

Primary completion

2011-12-21

Completion

2012-03-05

Outcome

Met primary endpoint

registry MEAN Denosumab 60 mg Q6M: 2.0 (1.8 to 2.3) Percent Change From Baseline NCT00919711 ↗

registry analysis (unspecified test); Risedronate 150 mg QM vs Denosumab 60 mg Q6M; p <0.0001; Mean Difference (Net) 1.6 (95% CI 1.2 to 2.0); ANCOVA NCT00919711 ↗

Publications

• Background Roux C, Hofbauer LC, Ho PR, Wark JD, Zillikens MC, Fahrleitner-Pammer A, Hawkins F, Micaelo M, Minisola S, Papaioannou N, Stone M, Ferreira I, Siddhanti S, Wagman RB, Brown JP. Denosumab compared with risedronate in postmenopausal women suboptimally adherent to alendronate therapy: efficacy and safety results from a randomized open-label study. Bone. 2014 Jan;58:48-54. doi: 10.1016/j.bone.2013.10.006. Epub 2013 Oct 17.
• Miller PD, Pannacciulli N, Malouf-Sierra J, Singer A, Czerwinski E, Bone HG, Wang C, Huang S, Chines A, Lems W, Brown JP. Efficacy and safety of denosumab vs. bisphosphonates in postmenopausal women previously treated with oral bisphosphonates. Osteoporos Int. 2020 Jan;31(1):181-191. doi: 10.1007/s00198-019-05233-x. Epub 2019 Nov 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Actonel	Unknown	150 mg	Oral
Subject	Denosumab	Monoclonal antibody	60 mg	Subcutaneous

Indications